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NCT06786325 · ClinicalTrials.gov registry record · Phase 2

Wellcome Leap Psilocybin for OUD

A Phase 2 study of Opioid Use Disorder, sponsored by Anna Rose Childress, Ph.D..

Recruiting
Registry status
Phase 2
Development phase
36
Enrollment target
1
Study location

NCT06786325 is a Phase 2 study of Opioid Use Disorder that is actively recruiting participants, run by Anna Rose Childress, Ph.D.. The registered enrollment target is 36 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06786325, a Phase 2 study of Opioid Use Disorder, is actively recruiting participants, sponsored by Anna Rose Childress, Ph.D..

RECRUITING
Registry status
Phase 2
Development phase
36 participants
Enrollment target
1
Study location

Study Summary

Investigators will recruit 36 individuals on MAT for OUD for a double-blind, placebo-controlled design to determine whether PEX010 (25-mg/d) shows preliminary efficacy on neural correlates of neurocognition and on clinical outcomes. Participants will be randomized to either (single dose) 25-mg (PEX010-25 group) or 1-mg (PPEX010-1 group) PEX010 in a 2:1 ratio. Brain and behavioral testing sessions will precede Psilocybin (PSI) dosing day by 24-48 hours and will follow PSI dosing by 1 week. After an initial 6 phases, participants will come into the lab to submit a urine screen 2x/week and to complete a short survey in order to collect data on drug use, MAT adherence, and mental health symptoms. The investigators hypothesize the PEX010-25 (vs. PEX010-1) group will have better clinical outcomes (e.g., lower average percent positive urine drug screens, more late relapses, higher MAT adherence). There are research follow ups every three months out to one year post dose.

Conditions Studied

Opioid Use Disorder

Interventions

  • DRUG Psilocybin

Study Locations (1)

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2025-10-07
Est. Completion 2027-10
Phase Phase 2

Sponsor

Anna Rose Childress, Ph.D.

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06786325

The ClinicalTrials.gov registry entry for NCT06786325 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The listed sponsor is Anna Rose Childress, Ph.D., which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Psilocybin is the first listed.

NCT06786325 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT06786325 about?

NCT06786325 is a clinical study titled "Wellcome Leap Psilocybin for OUD". Investigators will recruit 36 individuals on MAT for OUD for a double-blind, placebo-controlled design to determine whether PEX010 (25-mg/d) shows preliminary efficacy on neural correlates of neurocognition and on clinical outcomes. Participants will be randomized to either (single dose) 25-mg (PEX0...

What is the current status of trial NCT06786325?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2025-10-07. Estimated completion is 2027-10.

What conditions does trial NCT06786325 study?

This clinical trial studies the following conditions: Opioid Use Disorder.

What interventions are being tested in trial NCT06786325?

The interventions under investigation include: Psilocybin (DRUG).

Who is sponsoring clinical trial NCT06786325?

This trial is sponsored by Anna Rose Childress, Ph.D., which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06786325 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.